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CompletedNCT07551570Updated Aug 20, 2026

Pharmacokinetics of VC005 Tablets in Subjects With Renal Impairment and Normal Renal Function

A Phase 1 interventional study of VC005 Tablets in Renal Impairment, sponsored by Jiangsu vcare pharmaceutical technology co., LTD. Completed at 1 site in China. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-20.

Sponsored by Jiangsu vcare pharmaceutical technology co., LTD · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
32
Allocation
Non-randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

This study is a Phase I, single-dose, open-label trial designed to evaluate the pharmacokinetics and safety of a single oral dose of 25 mg VC005 tablets in participants with renal impairment compared to participants with normal renal function.

02

Conditions studied

  • Renal Impairment

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03

In context

Renal Insufficiency

1,995 studies on the registry are indexed under Renal Insufficiency; 173 are open to participants now.

This study's enrollment of 32 is below the median of 43 across 1,504 interventional studies indexed under Renal Insufficiency.

Browse Renal Insufficiency studies →

Lead sponsor

Jiangsu vcare pharmaceutical technology co., LTD is the lead sponsor of 34 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Voluntarily sign the informed consent form prior to the trial, fully understand the trial content, procedures, and possible adverse reactions, and be able to complete the study in accordance with the protocol requirements;
  2. Participants (including their partners) are willing to have no pregnancy plan from screening until 3 months after the last study drug administration and voluntarily take effective contraceptive measures; and have no plans to donate sperm or eggs;
  3. Male and female participants aged 18 to 70 years (inclusive);
  4. Male participants weighing no less than 50.0 kg, female participants weighing no less than 45.0 kg. Body mass index (BMI) between 18 and 32 kg/m² (inclusive).

Exclusion criteria

Exclusion Criteria:

  1. History of allergies, including to drugs, food, dust mites, etc., known allergy to the study drug or any of its components;
  2. History of drug abuse, drug addiction and/or alcohol abuse (consumption of 14 units of alcohol per week: 1 unit = 285 mL beer, or 25 mL spirits, or 100 mL wine); positive results in drug abuse screening and alcohol screening;
  3. Blood donation or significant blood loss (> 400 mL) within 3 months prior to screening; or plan to donate blood during the trial;
  4. Average daily smoking of more than 5 cigarettes within 3 months prior to screening; or inability to stop using any tobacco products during the trial;
  5. History of recurrent herpes zoster, disseminated herpes zoster, or disseminated herpes simplex;
  6. Known active bacterial, viral, fungal, parasitic infection or other infection, or any infectious event requiring antibiotic treatment or hospitalization (within 4 weeks prior to screening), or any acute infection within 2 weeks of baseline;
  7. History of dysphagia or, within 6 months prior to screening, any gastrointestinal conditions affecting drug absorption or excretion (e.g., reflux esophagitis, peptic ulcer, chronic diarrhea, chronic constipation), history of liver disease (regardless of cure), and history of surgery (e.g., gastrointestinal surgery and other major surgeries).
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
32 participants (actual)

Study arms

  • Experimental
    Normal Renal Function

    Drug: VC005 Tablets

  • Experimental
    Mild Renal Impairment

    Drug: VC005 Tablets

  • Experimental
    Moderate Renal Impairment

    Drug: VC005 Tablets

  • Experimental
    Severe Renal Impairment

    Drug: VC005 Tablets

Interventions

  • DrugVC005 Tablets

    Oral single dose

06

What researchers measure

Primary outcomes

  1. Area under the plasma concentration-time curve(AUC)

    Time frame: Day1-Day3

  2. Maximum Observed Plasma Concentration (Cmax)

    Time frame: Day1-Day3

07

Study locations

1 site
  • The First Affiliated Hospital of Bengbu Medical University
    Bengbu, Anhui 233000, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07551570
Lead sponsor
Jiangsu vcare pharmaceutical technology co., LTD
Responsible party
Sponsor
First posted
Apr 27, 2026
Start date
May 9, 2026
Primary completion
Aug 2, 2026
Completion
Aug 12, 2026
Last update
Aug 20, 2026

Study contacts

Huan Zhou
principal investigator · The First Affiliated Hospital of Bengbu Medical University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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